Associate Director, Promotion Compliance

Otsuka Pharmaceutical Co.; United States; Remote; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company as a Regulatory Compliance Specialist, where your expertise in US regulations and promotional labeling will play a crucial role in ensuring compliance for innovative pharmaceutical products. You will be responsible for reviewing and approving promotional materials, providing training on regulatory standards, and collaborating with multifunctional teams to enhance product communication. This is an exciting opportunity to contribute to a leading organization dedicated to improving patient outcomes through responsible promotion and compliance. If you are passionate about regulatory affairs and thrive in a dynamic environment, this role is perfect for you.

Qualifications

• 4+ years of experience in promotional compliance and product labeling.
• Solid understanding of US regulatory requirements and clinical concepts.

Responsibilities

• Review and approve promotional labeling materials for compliance.
• Serve as primary contact with FDA for advertising and promotion matters.

Skills

US regulatory requirements

clinical medicine

clinical pharmacology

medical concepts and terminology

pharmaceutical industry drug development

strong written communication

strong oral communication

ability to work across multifunctional groups

dealing with ambiguity

Education

Bachelor's Degree in life sciences

Advanced Degree in related field

Tools

MS Office

Veeva PromoMats

CREDO

Adobe Acrobat

Outlook

Teams

Job description

Job Summary

Independently reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be effective in managing work and resolving conflicts. Must demonstrate a high level of understanding of regulations related to promotion compliance. May be assigned additional responsibilities as deemed necessary.

Job Description

• Directs or assists junior staff member(s) or independently reviews, revises and approves content and context required of promotional labeling materials for prescription drug and medical device products.
• Ensures that promotional labeling and training material meet regulatory and company requirements. Provides alternative suggestions to allow for consistent messaging.
• Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working relationships and managing communication with OPDP reviewers for advertising and promotion matters, including advisory comments.
• Provides training to OAPI/OPDC employees on regulations for labeling and promotion compliance as appropriate.
• Monitors and informs others of changes in US labeling and promotional regulations as well as corporate policies and procedures, as appropriate.
• Recommends improvements to labeling policies, processes, quality, and system tools. Manages contracts for contractors and consultants.
• Contributes to SOPs for review and submission of advertising and promotional materials. Implements strategies to apply labeling updates that impact promotional materials.
• Collaborates with all review team members during development of promotional materials or other types of product communications to provide comprehensive regulatory compliance guidance.
• Ensures product promotional materials are submitted to OPDP on Form FDA 2253 in a timely manner as per regulations, and that materials are archived as per company policy.

Qualifications/ Required

Knowledge/ Experience and Skills:

• Solid understanding of US regulatory requirements
• Broad knowledge of clinical medicine and clinical pharmacology
• Excellent understanding of medical concepts and terminology
• Solid understanding of the structure and function of the product labeling
• Fundamental understanding of the pharmaceutical industry drug development process

Preferred:

• Able to work across multifunctional groups
• Strong written and oral communication skills
• Good computer skills including experience with MS Office: Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat.
• Capable of dealing with ambiguity and comfortable working with multifunctional teams

Educational Qualifications

• Bachelor's Degree required (life sciences disciplines strongly preferred)
• 4+ years of experience in promotional compliance and product labeling in the pharmaceutical industry
• Advanced Degree in related field is preferred

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies

• Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving: Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration: Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development: Play an active role in professional development as a business imperative.